Serum Institute gets preliminary approval to make Sputnik V vaccine

Pune: Adar Poonawalla’s Serum Institute of India has got permission from the country’s drugs regulator to make Sputnik V, the Russian COVID-19 vaccine. Poonawalla’s company will test, analyse and then manufacture the vaccine at its Pune plant, sources have said. The test licence granted to the Serum Institute means it can develop and manufacture the product for testing, but not sell it.

“We have got preliminary approval for Sputnik V. But actual manufacturing will take several months. In the meantime, our focus remains Covishield and Covovax,” Serum Institute of India’s (SII) spokesperson said.

The first dose of Sputnik V was administered in Hyderabad on May 14 as part of a soft launch by Dr Reddy’s Laboratories.

The Russian jab has now been registered for use in more than 65 countries but has yet to be approved by the EU or US health authorities.

At 91.6 per cent, Sputnik V has a higher efficacy compared to the two vaccines that are currently being administered in India – Oxford-AstraZeneca’s Covishield, manufactured by the SII, and Bharat Biotech’s Covaxin.

Russia registered with its drugs regulator Sputnik – named after the Soviet era satellite – in August last year ahead of large-scale clinical trials. Trial results published in the medical journal The Lancet said that with two doses, it is more than 90 per cent effective in symptomatic cases.

Another Russian vaccine, Sputnik Light, could be the first single-dose vaccine to be used in India and Dr Reddy’s will have discussions with the government and the regulator this month for an immediate launch, the company said on May 14.

“We are working very closely with our Russian partner and the Gamaleya Institute on this. As you may be aware, Sputnik Light has already been approved in Russia. It demonstrated an efficacy of 79.4 per cent. This is a single-shot vaccine,” Deepak Sapra, the CEO of Dr Reddy’s, said in an interview.

“What it essentially is, is that it is the first shot of Sputnik,” he said, adding that a second dose would take the efficacy to up to 91.6 per cent.

The possibility of Sputnik Light as India’s first single-dose vaccine “depends on approval from the regulator and on the dialogue which we have with them and on the guidance we receive from the regulator,” he said.

An imported dose of Sputnik V costs Rs. 995.40 in India.

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